To provide preliminary data on the effects of armodafinil and Brief Behavioral Therapy for Insomnia (BBT-I) (alone or in combination) on insomnia in breast cancer patients receiving chemotherapy.

Secondary Objectives:

To provide preliminary data on the influence of armodafinil and BBT-I (alone or in combination) on cancer-related fatigue (CRF) in breast cancer patients receiving chemotherapy.

To provide preliminary data on the influence of armodafinil and BBT-I (alone or in combination) on QOL in breast cancer patients receiving chemotherapy.

To provide preliminary data on influence of armodafinil and BBT-I (alone or in combination) on endocrine and inflammatory physiological markers (measured by cortisol and inflammatory cytokines markers)

Be scheduled for planned cancer treatment with chemotherapy or biologics, such as Herceptin (prior chemotherapy and diagnosis of metastatic breast are allowed)

Have at least 6 weeks of treatment remaining

Be at least 21 years old

Be able to swallow medication

Exhibit onset or worsening of problems falling or staying asleep

Exclusion Criteria:

Have ever taken armodafinil or modafinil

Have an unstable medical or psychiatric illness (Axis I - current or within the last 5 years)

Have a history of or uncontrolled cardiac disease, hypertension, severe headaches, glaucoma, or seizures

Have taken a psycho-stimulant medication within the past 28 days

Be currently pregnant or nursing

Have a history of substance abuse or meet criteria for current alcohol abuse or dependence

Have a self-reported history of chronic, preexisting insomnia, sleep apnea, or RLS syndrome

Have taken sleep medication daily for the last 28 days continuously

Have severe hepatic impairment

Be taking anti-seizure medications

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01011218